BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH SELECT STEERABLE SHEATH

    MDR report key: 10817375 · Received November 10, 2020

    Report

    Report Number
    3002648230-2020-00579
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DYB
    UDI-DI
    00763000279905
    PMA / PMN Number
    K142684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 990065 SHEATH WITH LOT 0009989396 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE SHAFT SHOWED IT WAS KINKED AT 1.31 INCHES FROM THE TIP. THE SHAFT TIP WAS INTACT WITH NO APPARENT ISSUES. IN CONCLUSION, THE REPORTED SHAFT KINK WAS CONFIRMED THROUGH TESTING. THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A SHAFT KINK. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY PROCEDURE, A SHEATH KINK WAS NOTED. THE SHEATH WAS REPLACED WITH RESOLUTION. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284855 FLEXCATH SELECT STEERABLE SHEATH INTRODUCER, CATHETER DYB MEDTRONIC CRYOCATH LP 990065 0009989396 00763000279905

    Patients

    Seq Age Sex Outcome Treatment
    1